Natco Pharma's API plant in Hyderabad gets U.S. FDA observation
Generic drugmaker Natco Pharma's active pharmaceutical igredients (API) manufacturing plant in Mekaguda, Hyderabad, has been issued a Form 483 with one observation by the U.S. Food and Drug Administration. The U.S. FDA conducted the inspection from June 9-13, and on conclusion, the company received one observation in the Form-483. The company believes it is procedural in nature and is confident to address the observation comprehensively, Natco Pharma said in a filing on Friday.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
22 minutes ago
- Time of India
Syngene International shares in focus after positive USFDA updates for 2 Bengaluru facilities
Shares of Syngene International are expected to be in focus on Monday, June 16, 2025, after the company received two significant updates from the United States Food and Drug Administration (USFDA) concerning inspections at its facilities in Bengaluru. The first update relates to a Good Clinical Practices (GCP) compliance inspection conducted at Syngene's Semicon Park facility, Bengaluru, from June 9 to June 13, 2025. The inspection concluded with zero observations, and no Form 483 was issued. The inspection was classified as 'No Action Indicated' (NAI), signifying full compliance with regulatory expectations. In a separate development, the USFDA also concluded its review of an earlier inspection held between February 10 and February 20, 2025, at Syngene's GMP manufacturing facilities in Biocon Park, SEZ, Bengaluru. The company received the Establishment Inspection Report (EIR) on June 11, 2025. The inspection was classified as 'Voluntary Action Indicated' (VAI), and the USFDA has accepted Syngene's responses and Corrective and Preventive Action (CAPA) plans submitted in response to the inspectional findings. These updates indicate regulatory progress and compliance, which could be seen positively by the market. Also read: Bajaj Finance stock split, bonus issue: Here's how your 10 shares will turn into 100 Live Events The company has stated that it will continue to provide periodic updates to the USFDA and remains committed to the highest standards of compliance. It also clarified that the inspection outcomes will not have any adverse impact on its financials or operations. In a separate regulatory filing, the company also confirmed the resignation of Ms. Priyadarshini Mahapatra from the position of Head Legal, Company Secretary & Compliance Officer, effective from the close of business hours on June 9, 2025. Her resignation was previously communicated on April 23, 2025. Syngene International shares closed 1.6% lower at Rs 652.50 on the BSE. ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
Time of India
an hour ago
- Time of India
Sun Pharma shares in focus after US FDA issues eight observations for Halol facility
Sun Pharma shares will be in focus on Monday after the company announced that the U.S. Food and Drug Administration (FDA) issued a Form-483 with eight observations for its Halol facility. The observations followed a Good Manufacturing Practices (GMP) inspection conducted between June 2 and June 13, the company said in a regulatory filing on Saturday. 'This is further to our update on Halol dated 16 December 2022,' the company said, referring to the warning letter the U.S. FDA had issued to the facility. The warning letter came close on the heels of the regulator placing the Halol facility under an import alert. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Kulkas yang belum Terjual dengan Harga Termurah (Lihat harga) Cari Sekarang Undo The warning letter had summarised violations concerning current good manufacturing practice (cGMP) regulations. The Halol plant, one of Sun Pharma's key manufacturing units, was last inspected in May 2022 and remains under an import alert. Also Read: These 11 Nifty microcap stocks can rally 55-210% in the next 12 months Live Events Sun Pharma reported a 19% year-on-year decline in consolidated net profit for the March quarter at Rs 2,154 crore, compared with Rs 2,659 crore a year earlier. Revenue from operations rose 8% YoY to Rs 12,959 crore, up from Rs 11,983 crore in the corresponding period last year. However, on a sequential basis, both profit and revenue declined. Profit after tax fell 26% from Rs 2,913 crore in Q3FY25, while revenue dropped 5% from Rs 13,675 crore. For the full financial year, net profit stood at Rs 10,965 crore, up from Rs 9,610 crore in the previous year. Total revenue rose 8.5% to Rs 52,578 crore from Rs 48,497 crore. Also Read: 10 midcap stocks with more than 20 buy Calls: Analysts see up to 25% upside Sun Pharma share price performance and outlook According to Trendlyne, the average target price for Sun Pharma is Rs 1,981, suggesting a potential upside of about 17% from current levels. Among 36 analysts tracking the stock, the majority have a 'Buy' rating. Technically, the stock's Relative Strength Index (RSI) stands at 46.2, indicating neutral momentum. The MACD is at 15.0, is below its Centre Line; this is a bearish indicator. Also Read: Swiggy, Radico Khaitan among 7 stocks on which brokerages initiated coverage, see up to 34% upside Sun Pharma shares closed 0.1% higher at Rs 1,688.7 on the BSE in the previous session, while the Sensex fell 0.7%. The stock is down 11% year-to-date and has dropped 7% over the past six months. ( Disclaimer : Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of the Economic Times)
Economic Times
3 hours ago
- Economic Times
Stocks in news: Adani Enterprises, Sun Pharma, Vedanta, Nazara Tech, NTPC
Markets remained under pressure and declined by over a percent in the week gone by, weighed down by rising geopolitical tensions and mixed global cues. In today's trade, shares of Adani Enterprises, Sun Pharma, Vedanta, Nazara Tech, NTPC among others will be in focus due to various news developments. ADVERTISEMENT Adani Enterprises Indian conglomerate Adani group's Chief Financial Officer Jugeshinder Robbie Singh on Sunday said reports of company's Haifa port in Israel being harmed by the Iranian ballistic missile attack are false. Bajaj Finance Shares of Bajaj Finance will trade ex-bonus and ex-stock split starting June 17. The company had announced a 4:1 bonus issue and a stock split of Rs 2 face value shares into two shares of Rs 1 each alongside its Q4 results. Sun Pharma Sun Pharmaceutical confirmed that the US FDA concluded an inspection of its Halol facility with eight observations in a Form 483. Vedanta Vedanta said it will hold a board meeting on June 18 to consider its first interim dividend proposal for FY26. The record date has been set for June 24. Nazara Technologies Investor Rekha Jhunjhunwala sold over 27 lakh shares of Nazara Technologies on June 13, reducing her stake in the gaming firm. ADVERTISEMENT Syngene International Syngene International received an EIR from the US FDA for its GMP manufacturing facilities in Biocon Park. NTPC ADVERTISEMENT State-run power producer NTPC has started commercial operations of Unit-3 (660 MW) at its North Karanpura Super Thermal Power Project. ITC ITC announced the completion of its acquisition of 100% stake in Sresta Natural Bioproducts (SNBPL) for Rs 400 crore. SNBPL and its overseas arms in the US and UAE now become wholly owned subsidiaries of ITC. ADVERTISEMENT Birla Corporation Birla Corporation has emerged as the preferred bidder for the Gourum Khan Ki Dhani (South) limestone block in Rajasthan. (You can now subscribe to our ETMarkets WhatsApp channel)
